MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0090
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised to address loosening of the femur bolt at the bone to implant interface.It was also reported that the patient underwent a 2 stage bilateral knee replacement revision surgery approximately 5 years ago at the hss in new york.Patient was allergic to bone cement so the revision was done with sigma femoral sleeves and tc3 femurs with a mbt revision tibia with sleeves on both the right and left without using cement.Femur on right side was unsupported by bone and had developed metal debris from the zero bolt and sleeve adapter.Surgeon removed femur and replaced with a distal femur on the right side.Sleeves on both sides were well fixed on the right side.Doi: (b)(6) 2015, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10656222
• Report Number: 1818910-2020-21843
• Device Sequence Number: 19720793
• Product Code: JWH
• UDI-Device Identifier: 10603295232575
• UDI-Public: 10603295232575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0090
• Device Catalogue Number: 960090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMA FEM POST AUG SZ5 8MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA DIS AUG 8MM,SZ5,RGHT; PFC*SIGMA DIS AUG 8MM,SZ5,RGHT; PFC*SIGMA TC3 FEM RT SZ5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S5,10.0; UNK KNEE TIBIAL TRAY SIGMA ; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE TIBIAL SLEEVE; PFC SIGMA FEM POST AUG SZ5 8MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA DIS AUG 8MM,SZ5,RGHT; PFC*SIGMA DIS AUG 8MM,SZ5,RGHT; PFC*SIGMA TC3 FEM RT SZ5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S5,10.0; UNK KNEE TIBIAL TRAY SIGMA ; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE TIBIAL SLEEVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 87